Effects of Aerosolized Dexamethasone on Acute Subglottic Injury

1992 ◽  
Vol 101 (1) ◽  
pp. 95-99 ◽  
Author(s):  
Thomas C. Kryzer ◽  
Carlos Gonzalez ◽  
Lawrence P. A. Burgess
Keyword(s):  
Phase 1 ◽  
Control Group ◽  
Phase 2 ◽  
Histomorphometric Analysis ◽  
Untreated Control Group ◽  
Phase 1 Study ◽  
Two Phase ◽  
Phase Study ◽  
Significant Difference ◽  
Made In

Aerosolized dexamethasone was used in a two-phase study to determine the possible effects on acute subglottic injury in the ferret animal model. In phase 1, equivalent subglottic injuries were made in 10 animals by using the brush technique, and the animals were divided into two groups. The treatment group received aerosolized dexamethasone at 2, 4, and 6 hours postinjury. All animals were examined 2, 4, 6, and 24 hours after the injury. The clinical condition of each animal was evaluated and their airways were measured. The animals were then painlessly killed and the larynges were frozen, sectioned, and photographed at 1-mm intervals. A computer-linked digitizer pad was used to measure the subglottic dimensions. The results show a trend for the treated animals to have a larger subglottic airway as compared to the untreated (control) group. The phase 1 study suggests that there may be an improvement in the subglottic airway when treated acutely with aerosolized dexamethasone. In phase 2, 20 additional animals were studied by using the same methods of injury and treatment as in phase 1. The subglottic airways of these animals were evaluated with histomorphometric analysis on fixed histologic sections. A statistically significant difference was found between the subglottic airways of the treated and untreated animals favoring treatment with aerosolized dexamethasone. Aerosolized dexamethasone appears to be beneficial in preserving the subglottic airway after injury, possibly secondary to decreasing the edema associated with injury.

Endometrial Adenocarcinoma in SurePath™ Cervical Samples: Cytological Features Revisited

2016 ◽  
Vol 60 (1) ◽  
pp. 46-52 ◽  
Author(s):  
Nalini Gupta ◽  
John Crossley ◽  
Nick Dudding ◽  
John H.F. Smith
Keyword(s):  
Phase 1 ◽  
Endometrial Adenocarcinoma ◽  
Nuclear Chromatin ◽  
Phase 2 ◽  
Cervical Lesions ◽  
Two Phase ◽  
Endometrial Cells ◽  
Phase Study ◽  
Cytological Features ◽  
Liquid Based Cytology

Objective: The cytomorphological criteria of malignant endometrial lesions in cervical samples are less well described than those of cervical lesions. We wished to investigate if there were features in SurePath™ liquid-based cytology samples that would facilitate more accurate differentiation between benign and malignant endometrial cells. Study Design: This was a two-phase study, with a review of all SurePath™ samples reported as endometrial adenocarcinoma (n = 42) evaluating 12 cytological features in the first phase. In phase 2 (test set), all initial cases plus an additional 83 cases were reviewed using these 12 cytological features to predict the outcome. Results: Out of 12 cytological features evaluated in phase 1 (training set), nuclear chromatin pattern, apoptotic bodies and tingible body macrophages were found to be the most significant features determining malignant histological outcome. These 12 cytological features were re-evaluated in phase 2 (n = 125). Of 125 cases, 54 had a benign and 71 had a malignant or premalignant histological outcome, with a positive predictive value of 56.8%. Conclusion: Granular nuclear chromatin, tingible body macrophages and apoptosis in the background are the most significant factors in determining whether endometrial cells present in cervical samples represent malignancy or are benign. Using these features, relatively accurate predictions of endometrial pathology can be made.

scholarly journals Development and Feasibility of a Kinect-Based Constraint-Induced Therapy Program in the Home Setting for Children With Unilateral Cerebral Palsy

2021 ◽  
Vol 9 ◽  
Author(s):  
Hao-Ling Chen ◽  
Szu-Yu Lin ◽  
Chun-Fu Yeh ◽  
Ren-Yu Chen ◽  
Hsien-Hui Tang ◽  
...  
Keyword(s):  
Cerebral Palsy ◽  
Phase 1 ◽  
Training System ◽  
Phase 2 ◽  
Two Phase ◽  
Clinical Trial Registration ◽  
Home Setting ◽  
Therapy Program ◽  
Phase Study ◽  
Block Test

Introduction: Cerebral palsy (CP) is the leading cause of childhood-onset physical disability. Children with CP often have impaired upper limb (UL) function. Constraint-induced therapy (CIT) is one of the most effective UL interventions for children with unilateral CP. However, concerns about CIT for children have been repeatedly raised due to frustration caused by restraint of the child’s less-affected UL and lack of motivation for the intensive protocol. Virtual reality (VR), which can mitigate the disadvantages of CIT, potentially can be used as an alternative mediator for implementing CIT. Therefore, we developed a VR-based CIT program for children with CP using the Kinect system.Aims: The feasibility of the Kinect-based CIT program was evaluated for children with unilateral CP using a two-phase study design.Materials and Methods: In phase 1, ten children with unilateral CP were recruited. To confirm the achievement of the motor training goals, maximal UL joint angles were evaluated during gameplay. To evaluate children’s perceptions of the game, a questionnaire was used. In phase 2, eight children with unilateral CP were recruited and received an 8 weeks Kinect-based CIT intervention. Performance scores of the game and outcomes of the box and block test (BBT) were recorded weekly.Results: In phase 1, results supported that the design of the program was CIT-specific and was motivational for children with unilateral CP. In phase 2, game performance and the BBT scores began showing stable improvements in the fifth week of intervention.Conclusion: It suggested the Kinect-based CIT program was beneficial to the motor function of the affected UL for children with unilateral CP. According to the results of this feasibility study, larger and controlled effectiveness studies of the Kinect-based CIT program can be conducted to further improve its clinical utility.Clinical Trial Registration: ClinicalTrials.gov, NCT02808195; Comparative effectiveness of a Kinect-based unilateral arm training system vs. CIT for children with CP

scholarly journals Implementation of a Pharmacist-Led Transitions of Care Program within a Primary Care Practice: A Two-Phase Pilot Study

Pharmacy ◽  
2020 ◽  
Vol 8 (1) ◽  
pp. 4 ◽  
Author(s):  
Erin Slazak ◽  
Amy Shaver ◽  
Collin M. Clark ◽  
Courtney Cardinal ◽  
Merin Panthapattu ◽  
...  
Keyword(s):  
Primary Care ◽  
Pilot Study ◽  
Primary Care Practice ◽  
Phase 1 ◽  
Transitions Of Care ◽  
Care Practice ◽  
Control Group ◽  
Phase 2 ◽  
Two Phase ◽  
Effective Manner

Pharmacists in primary care settings have unique opportunities to address the causes of ineffective care transitions. The objective of this study is to describe the implementation of a multifaceted pharmacist transitions of care (TOC) intervention integrated into a primary care practice and evaluate the effectiveness of the program. This was a two-phase pilot study describing the development, testing, and evaluation of the TOC program. In Phase 1, the TOC intervention was implemented in a general patient population, while Phase 2 focused the intervention on high-risk patients. The two pilot phases were compared to each other (Phase 1 vs. Phase 2) and to a historical control group of patients who received usual care prior to the intervention (Phase 1 and Phase 2 vs. control). The study included 138 patients in the intervention group (Phase 1: 101 and Phase 2: 37) and 118 controls. At baseline, controls had a significantly lower LACE index, shorter length of stay, and a lower number of medications at discharge, indicating less medical complexity. A total of 344 recommendations were provided over both phases, approximately 80% of which were accepted. In adjusted models, there were no significant differences in 30-day all-cause readmissions between Phase 2 and controls (aOR 0.78; 95% CI 0.21–2.89; p = 0.71) or Phase 1 (aOR 0.99; 95% CI 0.30–3.37; p = 0.99). This study successfully implemented a pharmacist-led TOC intervention within a primary care setting using a two-phase pilot design. More robust studies are needed in order to identify TOC interventions that reduce healthcare utilization in a cost-effective manner.

scholarly journals Texting Older Sisters to Step: The TOSS Study

2018 ◽  
Vol 41 (3) ◽  
pp. 388-408 ◽  
Author(s):  
Pamela G. Bowen ◽  
Olivio J. Clay ◽  
Loretta T. Lee ◽  
Wesley Browning ◽  
Yu-Mei Schoenberger ◽  
...  
Keyword(s):  
Physical Activity ◽  
African American Women ◽  
Phase 1 ◽  
Text Messages ◽  
Phase 2 ◽  
Two Phase ◽  
Contemplation Stage ◽  
Phase Study ◽  
Older African American Women ◽  
The Mean

The purpose of our two-phase study was to develop acceptable text messages to increase physical activity. Four focus groups (two for each phase) were conducted with older African American women who had access to texting-capable mobile phones and were in the contemplation stage for physical activity. The mean age of Phase 1 participants ( n = 12) was 71 and ranged from 65 to 86 years. Content analysis was used to identify fundamental themes that were later used to develop text messages. Six categories emerged from the data and 31 text messages were developed based on focus group input and national recommendations. The mean age of Phase 2 participants ( n = 9) was 67 and ranged from 65 to 75 years. Descriptive statistics revealed 100% of participants understood all messages. When messages were evaluated individually, a minimum of 78% felt each message motivated activity and 67% said lengths were perfect. Findings identified messages that were relevant and potentially motivational to stimulate physical activity among this population.

scholarly journals Effects of Three Acepromazine Doses on the Incidence of Morphine-Induced Vomiting, Sedation and Some Physiological Variables in Dogs

2017 ◽  
Vol 45 (1) ◽  
pp. 7 ◽  
Author(s):  
Eduardo Raposo Monteiro ◽  
Juliana Barros Pinto ◽  
Juarez Simões Nunes Junior ◽  
Julia Da Penha Piccoli Rangel
Keyword(s):  
Phase 1 ◽  
Primary Objective ◽  
Conscious Dogs ◽  
Control Treatment ◽  
Control Group ◽  
Phase 2 ◽  
Antiemetic Effect ◽  
Mean Values ◽  
Physiological Variables ◽  
Significant Difference

Background: Acepromazine was found to reduce the incidence of vomiting induced by opioids such as morphine, hydromorphone and oxymorphone in dogs. Despite the effectiveness of the phenothiazine in preventing opioid-induced vomiting in this species, a single dose of acepromazine (0.05 mg/kg) was tested and the influence of dose on the antiemetic effect of the drug is unknown. The primary objective of this study was to evaluate the effect of three acepromazine doses on the incidence of vomiting induced by morphine in dogs. A secondary aim was to assess the degree of sedation and effects on physiological variables following administration of the combinations tested.Materials, Methods & Results: All dogs received 0.5 mg/kg morphine (IM). Fifteen min before morphine, dogs in the Control, ACPLD, ACPMD and ACPHD groups were administered (IM) physiological saline or acepromazine at doses of 0.025, 0.05 and 0.1 mg/kg, respectively. In Phase 1, purpose-bred dogs (n = 8) underwent each of the four treatments in a randomized, crossover design; the incidence of vomiting, sedation, pulse rate (PR), systolic, mean and diastolic blood pressures (SAP, MAP and DAP) were investigated for 60 min. Sedation was assessed by a numeric descriptive scale (NDS, range 0-3) and a simple numerical scale (SNS, range 1-10). In Phase 2, client-owned dogs (n = 50) received a single treatment and only the incidence of vomiting was assessed. There was no significant difference between groups on the incidence of vomiting recorded in Phase 1, Phase 2 and the average of Phases 1 and 2. A significant decrease in PR was observed in most groups but no significant difference was detected between groups. Blood pressure decreased in all groups; during most of the evaluation period, SAP, MAP and DAP were significantly higher in the Control than in other treatments. Dogs in this study presented mild to intense sedation. A significant difference in NDS scores was observed between the Control and ACPMD groups whereas for SNS scores, significant differences were detected between the ACPMD and ACPHD groups compared with the Control group. The number of dogs presenting intense sedation as judged by the NDS (NDS score = 3) were: 1/8, 3/8, 3/8 and 4/8 dogs in the Control, ACPLD, ACPMD and ACPHD groups, respectively.Discussion: The hypothesis of the study was rejected. The acepromazine dose did not influence the frequency of morphineinduced vomiting, the degree of sedation or cardiovascular variables after administration of either treatment. The frequency of vomiting was high (≥ 75%) in dogs of the present study regardless of the treatment administered. There was no significant difference in the frequency of vomiting in ACPLD, ACPMD and ACPHD as compared to the Control group. This finding was unexpected because it has been reported in a previous study that acepromazine reduced the incidence of opioid-induced vomiting in dogs. ACPLD, ACPMD and ACPHD improved the quality of sedation compared to the Control treatment but no significant difference in sedation scores was observed among these groups. These findings suggest that, when combined to morphine, there is no improvement in sedation when the acepromazine dose is increased above 0.025 mg/kg in dogs. Despite a significant decrease, mean values of PR, SAP, MAP and DAP remained within the physiological range for conscious dogs. In summary, none of the acepromazine doses was effective in preventing morphine-induced vomiting in dogs. Sedation is greater after acepromazine-morphine combinations than after morphine alone and is not influenced by the acepromazine dose. Cardiovascular effects induced by combinations administered in this study were well tolerated and of little clinical relevance to healthy conscious dogs.

scholarly journals Does In-Person Visiting Affect the Number of COVID-19 Cases in Prisons?

Life ◽  
2021 ◽  
Vol 11 (11) ◽  
pp. 1184
Author(s):  
Lysandro Pinto Borges ◽  
Aline Fagundes Martins ◽  
Daniela Raguer Valadão de Souza ◽  
José Melquiades de Rezende Neto ◽  
Aryanne Araujo Santos ◽  
...  
Keyword(s):  
Risk Factors ◽  
The State ◽  
Nasopharyngeal Swab ◽  
Second Phase ◽  
Two Phase ◽  
Steady Growth ◽  
Phase Study ◽  
Significant Difference ◽  
Positive Results ◽  
Made In

Even with the current advances that have been made in regard to COVID-19, such as a better understanding of the disease and the steady growth in the number of vaccinated individuals, it remains a challenge for humanity. Dealing with the disease in prison settings has been particularly difficult. This study sought to discover whether in-person visiting affected the number of cases of SARS-CoV-2 infection in the penitentiaries in the state of Sergipe (Brazil). We conducted a two-phase study (when visiting was suspended and after it recommenced) in seven penitentiaries in Sergipe using immunochromatography and nasopharyngeal swab testing to evaluate whether visiting affects the number of COVID-19 cases. In the first phase (n = 778), 57.6% of inmates reported risk factors and 32.5% were positive for COVID-19 (18.9% IgM, 24.2% IgG, 1% antigen). In the second phase, 19.6% tested positive (13.9% IgM, 7.9% IgG, 0.2% antigen). The occurrence of positive cases of COVID-19 and positive results (IgM and IgG) were significantly higher in the first phase. In the second phase, 56.7% of inmates had received visits and 18.7% were positive for COVID-19 (14% IgM, 7% IgG). Among those who had not received visits, 20.9% tested positive (13.8% IgM, 9.2% IgG, 0.5% antigen). There was no significant difference in positive cases/results between inmates that had and had not received visits. These findings suggest that, under the conditions assessed, visiting does not seem to affect the number of COVID-19 cases in prisons and reinforces the importance of sanitary measures to control dissemination.

scholarly journals An Investigation Comparing the Efficacy of Topical Ocular Application of Tacrolimus and Cyclosporine in Dogs

2011 ◽  
Vol 2011 ◽  
pp. 1-5 ◽  
Author(s):  
Diane V .H. Hendrix ◽  
Elizabeth A. Adkins ◽  
Daniel A. Ward ◽  
Jamie Stuffle ◽  
Brian Skorobohach
Keyword(s):  
Keratoconjunctivitis Sicca ◽  
Phase 1 ◽  
Phase 2 ◽  
Efficacy And Safety ◽  
Two Phase ◽  
Topical Tacrolimus ◽  
Randomized Controlled ◽  
Schirmer Tear Test ◽  
Significant Difference ◽  
Trial Phase

The purpose of this paper was to determine the efficacy and safety of topical tacrolimus, compared to cyclosporine, for treating keratoconjunctivitis sicca (KCS) in dogs. This study was a two-phase, randomized, controlled, masked clinical trial. Phase 1 evaluated ophthalmic 0.03% tacrolimus in normal dogs. Ocular examinations were performed daily. Phase 2 evaluated the efficacy of tacrolimus in treating KCS. Half the dogs received 2% cyclosporine A; the others received 0.03% tacrolimus, both diluted in olive oil. Four ophthalmic examinations were done over 12 weeks. There was no significant difference between groups in phase I. In phase 2, there was no significant difference in Schirmer tear test I (STT) results between the two groups, and both groups had a significant increase in STT over time. Both drugs were effective in increasing the STT in dogs naïve to lacrimostimulants. Tacrolimus was effective in increasing the STT in 4 dogs currently nonresponsive to cyclosporine.

Safety evaluation of an antimalarial herbal product from Andrographis paniculata (AS201-01) in healthy volunteers

2021 ◽  
Vol 0 (0) ◽  
Author(s):  
Aty Widyawaruyanti ◽  
Arijanto Jonosewojo ◽  
Hilkatul Ilmi ◽  
Lidya Tumewu ◽  
Ario Imandiri ◽  
...  
Keyword(s):  
Blood Glucose ◽  
Healthy Volunteers ◽  
Day Treatment ◽  
Phase 1 ◽  
Andrographis Paniculata ◽  
Control Group ◽  
Healthy Human ◽  
Double Blind ◽  
Random Blood Glucose ◽  
Significant Difference

Abstract Objectives Andrographis paniculata tablets (AS201-01) have previously been shown to have potent bioactivity as an antimalarial and to produce no unwanted side effects in animal models. Here, we present the phase 1 clinical trial conducted to evaluate the safety of AS201-01 tablets in healthy volunteers. Methods The study was a randomized, double-blind controlled cross-over, a placebo-controlled design consisting of a 4-day treatment of AS201-01 tablets. A total of 30 healthy human volunteers (16 males and 14 females) were divided into two groups, and each group was given 4 tablets, twice daily for 4 days. Group 1 received AS201-01, while group 2 received placebo tablets. Volunteers were given a physical examination before the treatment. The effects of AS201-01 on random blood glucose, biochemical, and hematological as well as urine profiles were investigated. Results There were no changes in observed parameters as a result of AS201-01 being administered. Statistical analysis showed no significant difference (p>0.05) between the test and control group regarding hematology profile, biochemical profile, and random blood glucose. Increased appetite and better sleep, which categorized as grade 1 adverse event was reported after treatment with AS201-01 tablet Conclusions The outcome supports our previous observation that the AS201-01 tablet, given twice a day for 4 days, is safe and nontoxic.

scholarly journals Developing a realist theory of psychosocial rehabilitation: the Clubhouse model

2021 ◽  
Author(s):  
Christina Mutschler ◽  
Jen Rouse ◽  
Kelly McShane ◽  
Criss Habal-Brosek
Keyword(s):  
Phase 1 ◽  
Psychosocial Rehabilitation ◽  
Theory Development ◽  
Realist Evaluation ◽  
Self Determination ◽  
Phase 2 ◽  
Two Phase ◽  
Realist Theory ◽  
Clubhouse Model ◽  
Two Phases

Background Psychosocial rehabilitation is a service that supports recovery from mental illness by providing opportunities for skill development, self-determination, and social interaction. One type of psychosocial rehabilitation is the Clubhouse model. The purpose of the current project was to create, test, and refine a realist theory of psychosocial rehabilitation at Progress Place, an accredited Clubhouse. Method Realist evaluation is a theory driven evaluation that uncovers contexts, mechanisms, and outcomes, in order to develop a theory as to how a program works. The current study involved two phases, encompassing four steps: Phase 1 included (1) initial theory development and (2) initial theory refinement; and Phase 2 included (3) theory testing and (4) refinement. Results The data from this two-phase approach identified three demi-regularities of recovery comprised of specific mechanisms and outcomes: the Restorative demi-regularity, the Reaffirming demi-regularity, and the Re-engaging demi-regularity. The theory derived from these demi-regularities suggests that there are various mechanisms that produce outcomes of recovery from the psychosocial rehabilitation perspective, and as such, it is necessary that programs promote a multifaceted, holistic perspective on recovery. Conclusions The realist evaluation identified that Progress Place promotes recovery for members. Additional research on the Clubhouse model should be conducted to further validate that the model initiates change and promotes recovery outcomes.

Usefulness of Caerulein in the Treatment of Post-Operative Intestinal Atony

1980 ◽  
Vol 8 (1) ◽  
pp. 98-104 ◽  
Author(s):  
V Ferreira Montero ◽  
A Martinez Laganga ◽  
E Aznar Garcia
Keyword(s):  
Control Group ◽  
Controlled Clinical Trial ◽  
Test Drug ◽  
Untreated Control Group ◽  
Clear Cut ◽  
Test Product ◽  
Post Operative Period ◽  
Intravenous Drip ◽  
Intestinal Peristalsis ◽  
Made In

We conducted a controlled clinical trial designed “to test caerulein for tolerability and effectiveness in post-operative patients recovering from abdominal surgery. The test product was administered 24 hours after surgery, by intravenous drip infusion, at the rate of 2 nanograms/kg/minute. The results were compared with parallel observations made in a matched group of patients receiving no drugs or manipulation likely to promote intestinal peristalsis with the exception of the application of a nasogastric tube for aspiration and the water and electrolyte replenishment customary in the post-operative period. The results of this study evince a clear-cut difference between the two groups of patients in regard to the restoration of intestinal peristalsis and the passing of flatus and faeces, as confirmed by statistical analysis (Cochran's test) demonstrating the significant (p<0.01) superiority of caerulein treatment relative to the untreated control group. Likewise, the study revealed the excellent tolerability of the test drug at the dosage employed.

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